Kornimate/medical-research-clean huggingface dataset:
impact of germicidal light

Conditions: Bacterial Transmission; S.Aureus Transmission; Operating Room Exposure to S. Aureus; 90-day Postoperative Surgical Site Infections, Superficial and Deep

Summary: visible light at 405nm has been shown to be germicidal. the hypothesis is that use of this light (indigo-clean lights) in operating rooms will reduce s. aureus transmission occurring within and between patients and reduce surgical site infections (ssis). investigators will evaluate a case-control study where patients undergoing surgery with the lights are matched with patients undergoing surgery without germicidal lights.

operating room s. aureus exposure has been directly linked to postoperative infections and is therefore an important target for infection prevention. visible light at 405nm has been shown to be germicidal. investigators plan to install ambient, germicidal lighting (indigo-clean lights) that uses this wavelength in 4 operating rooms. patients will undergo surgery according to usual practice. investigators will conduct a case-control study where patients undergoing surgery with the lights are matched with patients undergoing surgery without the germicidal lights. patients will be matched by procedure then case duration then american society of anesthesiologists (asa) physical status health classification. these patients will undergo infection surveillance. infection surveillance will involve use of national healthcare safety network (nhsn) checklists applied to patients who are positive for one or more of the initial screening criteria (elevated white blood cell count, fever (\>38.4 degrees celsius), office note documentation of infection, positive culture (sputum, blood, urine, wound, other body fluid), or anti-infective order within the 90 postoperative day period.

Eligibility criteria:
inclusion criteria: * adult, at least 18 years old * adult patients undergoing orthopedic, cardiothoracic, gyn/onc, and neuro surgery and general anesthesia according to usual care with peripheral and/or central venous access. exclusion criteria: * pediatric (\<18 years old), * incarcerated, and/or * pregnant patients * undergoing surgery and/or without peripheral or central venous access. * undergoing surgery outside of the classifications above

Keywords: germicidal lights s. aureus transmission operating room s. aureus exposure
extending omalizumab treatment intervals in patients with chronic spontaneous urticaria

Conditions: Chronic Spontaneous Urticaria; Chronic Urticaria, Idiopathic

Summary: this study is a multicentre, randomized, open-label, non-inferiority clinical trial. the purpose and aim of this study is to investigate if patients with well controlled (uct score score ≥ 12) chronic spontaneous urticaria (csu) on omalizumab 300 mg every four weeks can extend treatment intervals and maintain disease control.

newly referred patients with csu who are well-treated (uct score ≥ 12) 12 weeks after initiating standard treatment with omalizumab 300 mg every four weeks, are randomized into two treatment arms.the first arm will continue standard treatment with omalizumab 300 mg every four weeks for 24 weeks. the second arm will receive treatment in an extended interval of omalizumab 300 mg every six weeks for 24 weeks.

Eligibility criteria:
inclusion criteria: * a diagnosis of csu according to the eaaci/ga2len/edf/wao guidelines. * age ≥ 18 years. * omalizumab-naïve prior to initiating treatment with omalizumab. * background treatment with four antihistamines daily. * candidate for omalizumab treatment according to danish guidelines. exclusion criteria: * pregnant or breastfeeding women. * planned pregnancy within the next 6 months. * weight ≥ 100 kilograms. * presence of any other active skin disease or condition that may interfere with the assessment of csu, such as atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis. * use of immunosuppressive drugs, such as prednisolone, azathioprine, methotrexate, or cyclosporine. * predominantly experience symptoms from chronic inducible urticaria (cindu). * inability to complete study or comply with study procedures. patients with a positive basophil histamine release assay (bhra) are not eligible for the study. patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive bhra test in the initial blood work.
camrelizumab combined with avd in the first-line treatment for patients with advanced classical hodgkin's lymphoma

Conditions: Classical Hodgkin Lymphoma

Summary: this is a prospective phase ii clinical trial to observe the efficacy and safety of camrelizumab combined with avd in the first-line treatment for patients with advanced classical hodgkin's lymphoma.

hodgkin's lymphoma (hl) is a kind of malignant tumor of the lymph system, approximately 95% of which are classical hodgkin's lymphoma (chl). currently, abvd and beacopp are commonly used in the first-line treatment for chl. there are about one third of patients, whose pre-treatment assessment are mainly advanced chl, suffering relapse and drug resistance. pd-1/pd-l1 signaling pathway plays an important role in the development and progression of chl. nivolumab and pembrolizumab have been used in the therapy in relapsed and refractory patients with chl. camrelizumab, a humanized anti-pd-1 igg4 monoclonal antibody, is independently developed in china. the goal of our trial is to assess the efficacy and safety of camrelizumab combined with avd (epirubicin, vincristine and dacarbazine) in the first-line treatment for patients with advanced classical hodgkin's lymphoma.

Eligibility criteria:
inclusion criteria: 1. age between 18 to 75 years old (including 18 and 75) 2. diagnosed as advanced classical hodgkin's lymphoma based on histopathology 3. subjects must be untreated (ann arbor stage iii/iv or ann arbor ii with b symptoms along with mediastinal big tumor or extranodal changes) 4. no receiving chemotherapy before enrollment 5. having at least one measurable lesions 6. world health organization-eastern cooperative oncology group performance status (ecog) 0-2 7. life expectancy no less than 3 months 8. enough main organ function 9. pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study 10. agreeing to sign the written informed consents exclusion criteria: 1. diagnosed as nodular lymphocyte predominant lymphoma or grey-zone lymphoma 2. diagnosed as central nervous system lymphoma 3. usage of immunosuppressants before enrollment and the dose of immunosuppressant used \>10mg / day oral prednisone for more than 2 weeks 4. previously treated with anti-pd-1/pd-l1/pd-l2/ctla-4 5. active autoimmune disease 6. vaccination with anti-tumor vaccine or other immune treatments less than 3 months 7. serious surgery and trauma less than two weeks 8. other malignant tumor history or active malignant tumor need be treated 9. systemic therapy for serious acute/chronic infection 10. congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months 11. active tuberculosis 12. vaccination with live attenuated vaccine less than 4 weeks 13. hiv-positive, aids patients and untreated active hepatitis 14. researchers determine unsuited to participate in this trial

Keywords: classical hodgkin lymphoma pd-1/pd-l1 signaling pathway camrelizumab
neuro 1 vs. neuro 2 sound processors

Conditions: Hearing Loss, Sensorineural; Cochlear Hearing Loss

Summary: this study evaluates the benefit of neuro 1 sound processor upgrade in speech perfomance in adults. half of participants will be tested with neuro 1 first and neuro 2, while the other half will be tested with neuro 2 first and then neuro 1.

the neuro 1 processor represented a technological advancement over past models, particularly in detecting the environment and automatically adjusting to the sound environment. a second version of the neuro 1 processor has been developed, the neuro 2. the signal processing and stimulation characteristics are similar, so speech comprehension levels are expected to be equivalent. this study is designed to compare neuro 1 and neuro 2 in terms of audiometric performance.

Eligibility criteria:
inclusion criteria: * written informed consent * primary implantation * subject having participated to previous neuro 1 sound processor study in canada * fluent in english, including reading and writing. exclusion criteria: * psychologically unsuitable * unrealistic expectations regarding possible benefits, risks, and limitations that are inherent to the device * non compliant with all investigational requirements.

Keywords: cochlear implant sound processor upgrade
sequencing t-cells in type i diabetes mellitus

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: the purpose of this study is to investigate cd8 + t-cell receptor (tcr) repertoire differences between patients with type 1 diabetes mellitus and type 2 diabetes or healthy controls.

using a systems biology approach by combining high-throughput sequencing, cytometry, gene expression, transcriptome profiling, hla typing, single cell analysis, and tcr affinity assays, the investigators will define a set of immune metrics for the prediction or early diagnosis of disease that is superior to the current examination of auto-antibodies, which is a fairly late stage in the disease development. this can also be used to guide therapy in advanced disease.

Eligibility criteria:
inclusion criteria: * patients must have a current or previous diagnosis of type i diabetes (autoimmune-related t1da as confirmed by a positive test for glutamic acid decarboxylase (gad) auto-antibodies. when available, idiopathic t1db patients with a lack of autoantibodies to gad will be recruited) * patients must be ≥ 18 years old and ≤55 years old inclusion criteria: patients t2d as controls * patients must have a current or previous diagnosis of t2d * patients must be ≥ 18 years old and ≤55 years old exclusion criteria: • \ 55 years old
probiotics as adjunctive migraine prophylaxis

Conditions: Migraine; Episodic Migraine

Summary: this study will assess the safety and efficacy of multi-strain probiotics as an adjunctive treatment for episodic migraine

this is a phase 2 and single center, randomized, placebo-controlled double-blind clinical trial. episodic migraine patients according to international headache society criteria will be allocated randomly into two treatment arms. one group will receive active probiotics and another group will receive placebo for treatment phase. both groups of patients will consume the treatment twice daily for 12 weeks and assessment will be made at baseline, baseline, week 4, 8 and 12

Eligibility criteria:
inclusion criteria: 1. subjects fulfilling criteria for episodic migraine as per the third edition of the international headache society (ichd-3) (table 1) 2. patients diagnosed with episodic migraine (4 or more episodes per month) for a minimum of 3 months. 3. on a steady treatment regimen: preventive and acute migraine medications and therapies unchanged over the last 3 months 4. adult patients age \> 18 years old 5. a signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments. exclusion criteria: 1. lactose intolerance 2. previous history of small and large bowel surgery 3. use of probiotics or antibiotics in 2 weeks before baseline visit. 4. patients with medical conditions such as severe hypertension, infections, 5. malignancy, cardiovascular and cerebrovascular diseases, epilepsy, degenerative central nervous system diseases, renal failure, hepatic failure, bleeding diathesis and serious mental illnesses 6. headache with red flags symptoms that may suggest organic secondary headaches. 7. onset of headache more than 50 years 8. prior gi infection in the previous 3-months 9. morbid obesity (bmi \>40) 10. pregnant or lactating women

Keywords: episodic migraine, probiotics, effectiveness, preventive treatment, randomized controlled trial.
lyt-100 in patients with bcrl

Conditions: Breast Cancer Related Lymphoedema; Lymphoedema

Summary: this is a trial of up to 6-months duration for safety, tolerability, clinical efficacy assessments, pk and biomarkers analysis in breast carcinoma patients with secondary lymphoedema

this trial will utilize a randomised, double-blinded, placebo controlled design that will assess the safety, tolerability, and secondarily clinical efficacy of lyt-100 over a period of up to 6-months of dosing in breast carcinoma patients with secondary lymphoedema following sentinel lymph node biopsy and/or axillary node dissection, with or without radiation.

Eligibility criteria:
main inclusion criteria: 1. female or male between 18 and 80 years old (inclusive) at the time of informed consent. 2. at least 6 months since any type of breast cancer surgery (excluding fine needle aspiration biopsy \[fna\]), at the time of study screening. no intention to have breast reconstructive surgery, nipple reconstruction and/or tattooing during the course of the study. 3. at least 3 months since completion of all types of treatment for breast cancer, including but not limited to neoadjuvant, radiotherapy, chemotherapy and immunotherapy, at the time of study screening. 4. at least 3 months treatment of stable adjuvant treatment with hormonal or anti-her2 therapy at the time of screening, with no planned changes to this therapy throughout the duration of the study. 5. diagnosis of primary breast cancer, and without evidence of recurrence of breast cancer and/or metastasis for at least 6 months since breast cancer surgery, as determined at screening and baseline. 6. documented evidence of stage 1 or 2 lymphedema. 7. receiving standard of care compression or agreeable to using care compression, or no compression at all ≥ 4 weeks prior to screening and throughout the study. main exclusion criteria: 1. bilateral lymphoedema or history of bilateral axillary lymph node removal (i.e., sentinel lymph node or axillary lymph node dissection), or primary lymphoedema or lymphatic or vascular malformation, determined at screening. 2. chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to study drug administration; corticosteroids are permitted at the discretion of the pi. 3. recent history (in the 8 weeks prior to screening) of cellulitis, lymphangitis, dermatitis, necrotizing fasciitis, or current open wounds or sores in the affected extremity. 4. stage iii lymphoedema, or history of clinically diagnosed secondary lymphoedema greater than 4 years, determined at screening. 5. initiated use of compression or manual lymphatic drainage or other lymphoedema therapies at the start of the study within 4 weeks of the screening visit. rescreening is allowed following a course of stable compression regimen of \> 4 weeks.
cupping therapy on immune system in post covid -19

Conditions: Covid-19 Patients

Summary: purpose of this study is to investigate 1. the effect of dry cupping therapy on t-lymphocyte in post covid-19 patients. 2. the effect of dry cupping therapy on serum cytokine in post covid-19 patients. 3. the effect of dry cupping therapy on immunoglobulin iga. 4. the effect of dry cupping therapy on immunoglobulin igm. 5. the effect of dry cupping therapy on immunoglobulin igg. seventy six patients of both genders with deficiency in t-lymphocyte number,,higher level of serum cytokine and lower immunoglobulin iga,igm,igg after two weeks of recovery from covid-19 . age range from twenty one to sixty six years old .they participated in the study and recruited from surveillance unit of shobra general hospital .these patients recruited by phone and have been offered to participate in the programme.the patients were divided equally into two groups (a and b). assessment was done before and after treatment. t-lymphocyte, serum cytokine and immunoglobulin iga, igm and igg were analyzed by kenza 240 tx from fluorescence-labeled flow cytometry. disposable cupping therapy instrument was used in treatment of group (a) in addition to traditional medical treatment in the form of vitamin c, d and anticoagulant drugs. traditional medical treatment only was used in treatment of group (b).the obtained results of this study will determine the significant improvement of participated two groups. .

patient were selected randomly and distributed in two groups by computer generation. the sample size was calculated using the g\*power software (version 3.0.10). f-test manova within and between interaction effects was selected. considering a power of 0.80, an α level of 0.05 (2 tailed) and effect size of 0.39; two groups and response variables of five, a generated sample size of at least 38 participants per group was required and total sample size of 76 subjects.

Eligibility criteria:
inclusion criteria: * all patients with body mass index(bmi) 25.0-29.9 kg/m2 recruited two weeks post recovary from covid-19 and have lower t-lymphocyte and elevated cytokine all patients were clinically and medically stable.all patients recruited by phone and have been offered to participate in the programme.all patients will sign the informed consent before joining the study. age range from 21 to 66 years .subjects will be divided equally into two groups a,b. assessment will be done before and after treatment. exclusion criteria: patients will be excluded if they have any of the following criteria: 1. history of acute or chronic infections 2. hepatobiliary diseases 3. hematological diseases 4. urinary system diseases 5. nutrition and metabolism diseases 6. rheumatic diseases 7. endocrine diseases 8. circulatory system diseases 9. muscle trauma 10. hypertension further, if they fulfilled any of the following testing criteria 11. hepatitis c virus antibodies 12. human immunodeficiency virus antibodies 13. creatinine above 120 μmol/l 14. creatine kinase above 500 u/l 15. uric acid above 475 μmol/l, glucose above 7.0 mmol/l 16. c-reactive protein above 12.0 m.
anticoagulation after rfca

Conditions: Atrial Fibrillation

Summary: the anticoagulation therapy is needed when rhythm control strategy is applied in atrial fibrillation patients but adverse events such as major bleeding exist. this study aims to examine the prognostic inpact of the duration of anticoagulation after radiofrequency ablation of paroxismal atrial fibrillation in patients with low thromboembolic risk. paroxismal atrial fibrillation patients with 0 or 1 chads2-vasc score undergoing radiofrequency ablation is randomized into one month anticoagulation group and two months anticoagulation group after the procedure. thromboembolic event and adverse event including major or minor bleeding would be compared.

catheter based radiofrequency ablation has been used in more than a decade as a rhythm control therapy. recently, superior outcome to medical therapy has been constantly reported and the radiofrequency catheter ablation (rfca) became popular globally. it is recommended to anticoagulate patients who received rfca for atrial fibrillation at least two months after the procedure. however, a few reports suggest anticoagulation in selective patients according to chads2-vasc score. anticoagulants prevent thromboembolic event in atrial fibrillation but the risk of bleeding is increased in company. there is controversy in the duration of anticoagulation after rfca of atrial fibrillation. the investigators aimed to investigate the association with thromboembolic and bleeding event of anticoagulation duration after rfca of atrial fibrillation in patients with low thromboembolic risk. paroxismal atrial fibrillation patients with 0 or 1 chads2-vasc score who are undergoing rfca are included and randomized by 1:1 ratio to one month anticoagulation group and two months anticoagulation group after rfca. any patient with an evidence of intracardiac thrombus is excluded. the primary endpoint is thromboembolic event in 6 months after rfca and the secondary endpoint is bleeding event in 6 months after rfca.

Eligibility criteria:
inclusion criteria: * under 75 years old patients undergoing rfca for paroxismal atrial fibrillation chads-vasc score 0-1 exclusion criteria: * presence of intracardiac thrombus
building caregiver skills using a simulation-based intervention for care of head and neck cancer

Conditions: Head and Neck Cancer

Summary: patients with head and neck cancer and their caregivers face many challenges. these include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness. this study tests whether different forms of education and support can help family caregivers feel better prepared. to find out if education about caregiving and different kinds of support are effective, this study wants to compare approaches.one group includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses. the other group receives an educational booklet about caregiving in addition to usual care by their doctors and nurses. the caregiver also completes surveys about his or her emotions, distress, confidence as a care giver, and quality of life. in addition, the study asks the caregiver questions about his or her age, race, ethnicity, marital status, employment status, education, annual household income, and current living arrangements. this pilot study will only be offered at the case medical center, university hospitals seidman cancer center, case comprehensive cancer center main campus.

aim 1: conduct a pilot test of the effects of a novel caregiver intervention, as compared to a control group, on family caregiver self-efficacy for caregiving, anxiety, depression, and health-related quality of life. aim 2: explore the acceptability of a caregiver intervention that utilizes simulation. aim 3: assess the feasibility of the intervention. aim 4: describe the incidence of patient events that may be impacted by caregiver self-efficacy, such as acute care visits, admissions to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course.

Eligibility criteria:
inclusion criteria: * family member or friend of an adult patient with a new diagnosis of stage iii - iv cancers of the tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, larynx, or parotid who is receiving radiation therapy for curative intent * identified by the patient as his/her primary caregiver who is providing daily assistance and/or emotional support * cognitively intact, as evidenced by orientation to person, place, and time * ability to speak, read, and comprehend english exclusion criteria: * caregivers of patients who are receiving hospice care will be excluded because of the patient's poor prognosis and multiple issues associated with end-of-life care * caregivers who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed)

Keywords: caregiver simulation